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Not yet recruiting NCT07256327

Chiropractic for Kids With Sensory Processing Challenges

Observational Sensory Processing Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sensory Processing Disorder. Basic parameters: 5 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of Chiropractic on Kids With Sensory Processing Challenges: a Pilot Observational Study

Overview

The main aim of this pilot observational study is to investigate the feasibility of implementing our novel assessment battery in tandem with normal and customary chiropractic care in a practice-based setting using a pediatric population with parent-reported sensory processing disorder (SPD). The secondary aim is to assess potential changes in objective and subjective outcomes.

Detailed description

Twenty (20) parents \& children with probable or definite parent-reported SPD as determined by the Short Sensory Profile (SSP) will be enrolled. The primary outcomes are 1) eligibility, 2) tolerability, 3) adherence, and 4) retention. The secondary aim is to assess the potential effects of subluxation-based pediatric chiropractic care on electrocardiography (ECG)-derived heart rate variability (HRV) and parent-reported outcomes (PROs). Results from this study will inform the feasibility of a larger study powered to assess the effectiveness of pediatric chiropractic care on clinical outcomes in a pediatric population with SPD.

Primary outcome measures

  • Proportion of enrollees who are eligible to participate [Time frame: From enrollment to baseline SSP score evaluation (up to 1 hour)]
  • Proportion of participants able to tolerate the assessments [Time frame: From enrollment to baseline assessment completion (up to 1 hour)]
  • Proportion of participants adhering to the recommended care plan [Time frame: From enrollment to the end of participation (up to 10 weeks)]
  • Proportion of participants retained in the study [Time frame: From enrollment to the end of the 10 week study period.]
Secondary outcome measures (3)
  • Change in Heart Rate Variability (HRV) [Time frame: From enrollment to the end of participation (up to 10 weeks)]
  • Change in Short Sensory Profile (SSP) Scores [Time frame: From enrollment to the end of participation (up to 10 weeks)]
  • Change in Pediatric Autonomic Symptom Scales (PASS) Scores [Time frame: From enrollment to the end of participation (up to 10 weeks)]

Eligibility criteria

Inclusion criteria

  • 5-12 years of age.
  • SSP total scores ≤154

Exclusion criteria

  • A known heart condition, including pacemakers
  • Chiropractic care within the past 30 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Well Adjusted Students — Chippewa Falls

Identifiers

NCT: NCT07256327 · EXPTP011226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗